Niraparib tosylate - Generic Drug Details

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What are the generic drug sources for niraparib tosylate and what is the scope of patent protection?

Niraparib tosylate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Niraparib tosylate has two hundred and sixty patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for niraparib tosylate

International Patents:	260
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	3
Patent Applications:	15
DailyMed Link:	niraparib tosylate at DailyMed

Recent Clinical Trials for niraparib tosylate

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Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2
Eli Lilly and Company	Phase 1
National Cancer Institute (NCI)	Phase 1

See all niraparib tosylate clinical trials

Pharmacology for niraparib tosylate

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

US Patents and Regulatory Information for niraparib tosylate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing		Y		See Plans and Pricing
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for niraparib tosylate

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Country	Patent Number	Title	Estimated Expiration
Slovenia	2336120		See Plans and Pricing
Norway	20060906		See Plans and Pricing
Hong Kong	1079530	Phthalazinone derivatives	See Plans and Pricing
Austria	516353		See Plans and Pricing
Taiwan	200530196	DNA damage repair inhibitors for treatment of cancer	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for niraparib tosylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2109608	2018016	Norway	See Plans and Pricing	PRODUCT NAME: NIRAPARIB ELLER ET; REG. NO/DATE: EU/1/17/1235 20171127
1633724	13/2015	Austria	See Plans and Pricing	PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
2109608	132018000000263	Italy	See Plans and Pricing	PRODUCT NAME: NIRAPARIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, UN SUO STEREOISOMERO O TAUTOMERO, IN PARTICOLARE IL TOSILATO O UN IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120
1633724	213 50005-2015	Slovakia	See Plans and Pricing	PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
2109608	300937	Netherlands	See Plans and Pricing	PRODUCT NAME: NIRAPARIB, OF EEN TAUTOMEER DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1235 20171120
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.